Obturator

FDA UDI

Class II (US FDA UDI)

by SOPRO-COMEG GmbH

Identity

Trade Name: Obturator FDA UDI
Generic Name: Rigid endoscope obturator FDA UDI
Model / Reference: 195 900 070BC FDA UDI

Identifiers

Primary DI / UDI-DI: 04059082009957 FDA UDI
510(k) Number: K971881 FDA UDI
FDA Product Code: FDC FDA UDI
GMDN Term: Rigid endoscope obturator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscope obturator

Obturator by SOPRO-COMEG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid endoscope obturator.

Biportal Laminoscope, ocular — Joimax GmbH · Class IIa
TAUT — TELEFLEX INCORPORATED · Class II
Spinal surgery spongiosa pushers — Richard Wolf GmbH · Class I
USA Elite — Gyrus Acmi, Inc. · Class II
Trabecular Metal® — Zimmer, Inc. · Class I
SHARK — Richard Wolf GmbH · Class II
SUPERCUT — Karl Storz GmbH & Co. KG · Class II
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II

Cleared under the same submission

K971881 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: SOPRO-COMEG GmbH

Sources (1)

FDA UDI 9274f4ec-95fc-4e1f-aa72-e50aafbc3145 33 fields · synced Jun 1, 2026