Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Bipolar pencil, 18 gauge, non-stick, curved tip, packaged individually sterile, disposable, box of 10 FDA UDI
- Model / Reference
- PD7212 FDA UDI
- Description
- Bipolar pencil, 18 gauge, non-stick, curved tip, packaged individually sterile, disposable, box of 10 FDA UDI
Identifiers
- Catalog Number
- PD7212 FDA UDI
- Primary DI / UDI-DI
- 10190660000896 FDA UDI
- 510(k) Number
- K864402 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
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: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Ambler Surgical by Ambler Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, single-use.
- nxt™ Bipolar Forceps — adeor Medical AG · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
- AESCULAP — AESCULAP, INC. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
Cleared under the same submission
K864402 also covers:
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- Alpin — Alpin Surgical Specialties Inc
- Alpin — Alpin Surgical Specialties Inc
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 62230e93-16c7-47f0-8a93-b34e2b97dcc4 36 fields · synced May 30, 2026