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Sutter Swyng non-stick bipolar forceps, single-use

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K193587Ref 7844415STRef 7844915STRef 7844710STRef 7844405STIRef 7844905STIRef 7844110STIRef 7844810STRef 7844105SLRef 7844110STRef 7844405STRef 7844910STIRef 7844110SLRef 7844115STIRef 7844905STRef 7844410STIRef 7844415SL

by Sutter Medizintechnik GmbH

Identity

Trade Name
Sutter FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Device Name
Bipolar Forceps single-use EUDAMED
Swyng ® non-stick bipolar forceps, single-use, US 19 cm ST, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm SL, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 19 cm ST, bayonet, tip 1,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm ST, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm ST, bayonet, tip 1,0 x 6 mm, 45° angled upward FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 19 cm STI, bayonet, tip 1,0 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm STI, bayonet, tip 1,0 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm SL, bayonet, tip 1,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm ST, bayonet, tip 1,0 x 6 mm, 45° angled downward FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm STI, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm STI, bayonet, tip 1,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 19 cm STI, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm SL, bayonet, tip 1,0 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm STI, bayonet, tip 1,0 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm ST, bayonet, tip 1,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm ST, bayonet, tip 1,0 x 6 mm FDA UDI
Model / Reference
7844905ST EUDAMEDFDA UDI
7844105SL EUDAMEDFDA UDI
7844915ST EUDAMEDFDA UDI
7844405ST EUDAMEDFDA UDI
7844710ST EUDAMEDFDA UDI
7844910STI EUDAMEDFDA UDI
7844110STI EUDAMEDFDA UDI
7844415SL EUDAMEDFDA UDI
7844810ST EUDAMEDFDA UDI
7844405STI EUDAMEDFDA UDI
7844115STI EUDAMEDFDA UDI
7844905STI EUDAMEDFDA UDI
7844110SL EUDAMEDFDA UDI
7844410STI EUDAMEDFDA UDI
7844415ST EUDAMEDFDA UDI
7844110ST EUDAMEDFDA UDI
Description
Swyng ® non-stick bipolar forceps, single-use, US 19 cm ST, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm SL, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 19 cm ST, bayonet, tip 1,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm ST, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm ST, bayonet, tip 1,0 x 6 mm, 45° angled upward FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 19 cm STI, bayonet, tip 1,0 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm STI, bayonet, tip 1,0 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm SL, bayonet, tip 1,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm ST, bayonet, tip 1,0 x 6 mm, 45° angled downward FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm STI, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm STI, bayonet, tip 1,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 19 cm STI, bayonet, tip 0,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm SL, bayonet, tip 1,0 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm STI, bayonet, tip 1,0 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 24 cm ST, bayonet, tip 1,5 x 6 mm FDA UDI
Swyng ® non-stick bipolar forceps, single-use, US 21 cm ST, bayonet, tip 1,0 x 6 mm FDA UDI

Identifiers

Catalog Number
7844905ST FDA UDI
7844105SL FDA UDI
7844915ST FDA UDI
7844405ST FDA UDI
7844710ST FDA UDI
7844910STI FDA UDI
7844110STI FDA UDI
7844415SL FDA UDI
7844810ST FDA UDI
7844405STI FDA UDI
7844115STI FDA UDI
7844905STI FDA UDI
7844110SL FDA UDI
7844410STI FDA UDI
7844415ST FDA UDI
7844110ST FDA UDI
Primary DI / UDI-DI
ESUM7844905ST0 EUDAMEDFDA UDI
ESUM7844105SL0 EUDAMEDFDA UDI
ESUM7844915ST0 EUDAMEDFDA UDI
ESUM7844405ST0 EUDAMEDFDA UDI
ESUM7844710ST0 EUDAMEDFDA UDI
ESUM7844910STI0 EUDAMEDFDA UDI
ESUM7844110STI0 EUDAMEDFDA UDI
ESUM7844415SL0 EUDAMEDFDA UDI
ESUM7844810ST0 EUDAMEDFDA UDI
ESUM7844405STI0 EUDAMEDFDA UDI
ESUM7844115STI0 EUDAMEDFDA UDI
ESUM7844905STI0 EUDAMEDFDA UDI
ESUM7844110SL0 EUDAMEDFDA UDI
ESUM7844410STI0 EUDAMEDFDA UDI
ESUM7844415ST0 EUDAMEDFDA UDI
ESUM7844110ST0 EUDAMEDFDA UDI
Basic UDI-DI
++ESUMTD25784400HM EUDAMED
510(k) Number
K193587 FDA 510(k)
FDA Product Code
GEI FDA 510(k)FDA UDI
EMDN Code
K0201010601 OPEN ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMED
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Sutter Swyng non-stick bipolar forceps, single-use by Sutter Medizintechnik GmbH — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sutter Medizintechnik GmbH

Sources (33)

  • FDA 510(k) K193587 24 fields · synced Aug 4, 2026
  • FDA UDI affe62b8-c46a-4834-a6a0-6c52935a4cc1 35 fields · synced May 29, 2026
  • FDA UDI b41ca58e-5a50-451a-91a8-d016d59ee2d0 35 fields · synced May 29, 2026
  • FDA UDI 1750cf0e-2405-43a4-96fb-c8da4ffefb5f 35 fields · synced May 30, 2026
  • FDA UDI c4f393ac-7414-4f01-a67e-5f77b3d267d1 35 fields · synced May 30, 2026
  • FDA UDI 2ce74b50-a24d-4761-ad16-22bde20687bd 35 fields · synced May 30, 2026
  • FDA UDI 8e256d0c-691a-464e-b7d0-c06fede97709 35 fields · synced May 30, 2026
  • FDA UDI 80d43f5d-5cda-4ede-959f-20340f13d6e3 35 fields · synced May 30, 2026
  • FDA UDI 553a43e7-bdfe-4ffd-846d-9b82916eaf2f 35 fields · synced May 30, 2026
  • FDA UDI 3ae7e359-2e73-4ba1-b9cf-8548da2456f7 35 fields · synced May 30, 2026
  • FDA UDI b15078f1-93d0-4383-b371-262ec3e09ad0 35 fields · synced May 30, 2026
  • FDA UDI efaacbd1-b7e1-4156-a7a6-a9591676cf1a 35 fields · synced May 30, 2026
  • FDA UDI a86deb03-e248-40e4-9552-14ddf4f5a398 35 fields · synced May 30, 2026
  • FDA UDI bdace76f-6cca-4923-8f26-21d472e964f9 35 fields · synced May 30, 2026
  • FDA UDI fb86d1a8-e389-46f9-acb3-7aee277ad57f 35 fields · synced May 30, 2026
  • FDA UDI 3b90b376-12d8-4ff2-b47c-51858e33597f 35 fields · synced May 30, 2026
  • FDA UDI ce1e3c65-bdcb-4a0e-9aca-b404ca627524 35 fields · synced May 30, 2026
  • EUDAMED 7ca31a91-0ac5-4e11-a5fe-9fd1aa13a2b5 61 fields · synced Jun 20, 2026
  • EUDAMED 6c090e47-792f-483c-a348-1b7b63e3e1a8 61 fields · synced Jul 9, 2026
  • EUDAMED f7baaab8-6d77-450a-a5e7-9905093819e6 61 fields · synced Jul 9, 2026
  • EUDAMED 50b5b693-9952-4f13-8b5c-75279885996f 61 fields · synced Jul 10, 2026
  • EUDAMED 892a544c-7bd9-40e1-903c-293576a5d8d8 61 fields · synced Jul 14, 2026
  • EUDAMED 355b751a-37b9-4d94-ab59-698e6c5002ec 61 fields · synced Jul 14, 2026
  • EUDAMED a800c0e2-054e-47c7-a76b-0dfefb6fa0ce 61 fields · synced Jul 14, 2026
  • EUDAMED 54e66739-9167-4bb8-9582-842c058fdfbc 61 fields · synced Jul 15, 2026
  • EUDAMED df7a3502-b340-4e12-86ce-80f4b8d8a2e6 61 fields · synced Jul 16, 2026
  • EUDAMED 5a183de0-0711-40db-8a43-cc01918edfbb 61 fields · synced Jul 18, 2026
  • EUDAMED fb0a56ec-781a-40f1-8c8a-905f9c5b1d4c 61 fields · synced Jul 28, 2026
  • EUDAMED 5eba68c1-0769-454e-9eab-f99c59ac9ad7 61 fields · synced Jul 28, 2026
  • EUDAMED 4c769a90-22ef-43de-bb3c-8e798f019ab1 61 fields · synced Jul 31, 2026
  • EUDAMED 15e101b1-3330-4ff6-980f-d467cc41e4f0 61 fields · synced Aug 1, 2026
  • EUDAMED 450a89b8-4d59-46d0-894b-5dc30579ae91 61 fields · synced Aug 3, 2026
  • EUDAMED 4d6eefc9-517e-44cf-a7b5-d1140064843c 61 fields · synced Aug 4, 2026