Identity
- Trade Name
- Rectosigmoidoscope with Obturator FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052 FDA UDI
- Model / Reference
- UA0672 FDA UDI
- Description
- Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704916001353 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Rigid endoscope obturator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rigid endoscope obturator
Rectosigmoidoscope with Obturator by Bk Medical ApS — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope obturator.
- Arthroscopy bridge — SOPRO-COMEG GmbH · Class II
- Biportal Laminoscope, ocular — Joimax GmbH · Class IIa
- TAUT — TELEFLEX INCORPORATED · Class II
- Hysteroscopy obturator — SOPRO-COMEG GmbH · 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
Cleared under the same submission
K173569 also covers:
K180737 also covers:
K223830 also covers:
- Disposable Needle Guide — Bk Medical ApS
- Dummy Channel Bracket — Bk Medical ApS
- Dummy Channel Bracket — Bk Medical ApS
- Foot Switch — Bk Medical ApS
- Rectosigmoidoscope with Obturator — Bk Medical ApS
- Water Standoff Collar — Bk Medical ApS
- Wireless Remote Control — Bk Medical ApS
- Wireless Remote Control — Bk Medical ApS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Bk Medical ApS
Sources (2)
- FDA UDI 616b2a4c-8d0d-44bb-a61f-427bdbdbf258 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 18, 2026