Identity
- Trade Name
- SECULOCK FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- Strong atraumatic clamp, 10 mm, straight FDA UDI
- Model / Reference
- 13-1327SQI FDA UDI
- Description
- Strong atraumatic clamp, 10 mm, straight FDA UDI
Identifiers
- Catalog Number
- 13-1327SQI FDA UDI
- Primary DI / UDI-DI
- 04250302230612 FDA UDI
- 510(k) Number
- K974382 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
- 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
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Seculock by Ackermann Instrumente GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K974382 also covers:
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Novo Surgical — NOVO SURGICAL, INC.
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
- Ackermann Instrumente GmbH
Sources (1)
- FDA UDI 66f54c96-7dac-4fde-b4c9-5140971ac4ec 36 fields · synced Jun 1, 2026