Identity
- Trade Name
- MICROLAP FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- MICROLAP OBTURATOR, HELICAL 60 MM FDA UDI
- Model / Reference
- C-LIL-O-060H FDA UDI
- Description
- MICROLAP OBTURATOR, HELICAL 60 MM FDA UDI
Identifiers
- Catalog Number
- C-LIL-O-060H FDA UDI
- Primary DI / UDI-DI
- 10653405005872 FDA UDI
- 510(k) Number
- K140101 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Microlap by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K140101 also covers:
- "Allis" insert L=50cm D=5mm — Medica Corp.
- 20mm Tapered insert L=35cm D=5mm — Medica Corp.
- 30mm Fenestrated insert L=35cm D=5mm — Medica Corp.
- C35-"C" Shape Dissector, Jaw Insert L=33mm D=3, 5mm — Medica Corp.
- C35-20mm Fenestrated insert L=330mm D=3, 5mm — Medica Corp.
- C35-330mm insert with 2 movable Fenestrated jaws length 20mm D=3, 5mm — Medica Corp.
- C35-Allis Grasping Forceps, 2 mobile jaws Insert L=33mm D=3, 5mm — Medica Corp.
- C35-Bipolar Handle L 33cm D 3, 5mm — Medica Corp.
- C35-Classical HOOK L=330mm D=3, 5mm — Medica Corp.
- C35-Clutch 2 mobile jaws insert L 33cm D 3, 5mm — Medica Corp.
- C35-Clutch insert L=330mm D=3, 5mm — Medica Corp.
- C35-Hand Activated HOOK L=330mm — Medica Corp.
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 |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI d69d970e-6022-4b7d-9628-e98b531f7115 39 fields · synced Jun 1, 2026