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OTSC Proctology

FDA UDI

Class II (US FDA UDI)

by Ovesco Endoscopy AG

Identity

Trade Name
OTSC Proctology FDA UDI
Generic Name
Endoscopic manual linear stapler FDA UDI
Device Name
OTSC Proctology is an innovative clipping system to be applied in proctology procedures • it is used for wall closure in the anorectum (e.g. fistulae) • offers three unique advantages: large volume of tissue secured | high stability at the lesion site | minimal strain on surrounding tissue • exceptional properties and therapeutic functions are based on its special design and material: superelastic Nitinol • material is biocompatible, can be applied as a long-term implant • absorbable U-shaped sutures or the OTSC Proctology Anchor may be used to place the applicator cap precisely on the lesion FDA UDI
Model / Reference
14 t FDA UDI
Description
OTSC Proctology is an innovative clipping system to be applied in proctology procedures • it is used for wall closure in the anorectum (e.g. fistulae) • offers three unique advantages: large volume of tissue secured | high stability at the lesion site | minimal strain on surrounding tissue • exceptional properties and therapeutic functions are based on its special design and material: superelastic Nitinol • material is biocompatible, can be applied as a long-term implant • absorbable U-shaped sutures or the OTSC Proctology Anchor may be used to place the applicator cap precisely on the lesion FDA UDI

Identifiers

Catalog Number
200.60 FDA UDI
Primary DI / UDI-DI
04260206310266 FDA UDI
510(k) Number
K150067 FDA UDI
FDA Product Code
PKL FDA UDI
GMDN Term
Endoscopic manual linear stapler FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Endoscopic manual linear stapler

OTSC Proctology by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic manual linear stapler.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ovesco Endoscopy AG

Sources (1)

  • FDA UDI 178b8bca-9750-4d93-94bd-febc83f3da10 37 fields · synced Jun 6, 2026