Identity
- Trade Name
- AccuCirc® FDA UDI
- Generic Name
- Circumcision clamp, single-use FDA UDI
- Device Name
- AccuCirc® Circumcision Device FDA UDI
- Model / Reference
- CIRC-1350 FDA UDI
- Description
- AccuCirc® Circumcision Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020093 FDA UDI
- 510(k) Number
- K061539 FDA UDI
- FDA Product Code
- HFX FDA UDI
- GMDN Term
- Circumcision clamp, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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
Category: Circumcision clamp, single-use
AccuCirc® by Clinical Innovations, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Circumcision clamp, single-use.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
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- Circumplast — EMBOSS MEDICAL LIMITED · Class II
- Gomco Type Circumcision Clamp — FINE SURGICAL INSTRUMENTS INC. · Class II
- Circumplast — EMBOSS MEDICAL LIMITED · Class II
- Circumplast — EMBOSS MEDICAL LIMITED · Class II
- Circumplast — EMBOSS MEDICAL LIMITED · Class II
Cleared under the same submission
K061539 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
- Clinical Innovations, LLC
Sources (1)
- FDA UDI 3f167290-275a-4e46-816b-41dd07812c25 34 fields · synced Jun 9, 2026