Identity
- Trade Name
- Novo Surgical FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Cobra-Style Toothed Grasper - 3 Piece Modular Reusable Insert, insert only, 5.0 mm sheath diameter, double action, 10-1/4" (26.0 cm) FDA UDI
- Model / Reference
- 9000-27052RM FDA UDI
- Description
- Cobra-Style Toothed Grasper - 3 Piece Modular Reusable Insert, insert only, 5.0 mm sheath diameter, double action, 10-1/4" (26.0 cm) FDA UDI
Identifiers
- Catalog Number
- 9000-27052RM FDA UDI
- Primary DI / UDI-DI
- 00842331106330 FDA UDI
- 510(k) Number
- K974382 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 26 Centimeter FDA UDI
Category: Rigid endoscopic tissue manipulation forceps, reusable
Novo Surgical's Cobra-Style Toothed Grasper is a versatile and effective surgical instrument designed for endoscopic use. Made from high-quality materials, this reusable device features a modular design with a 5.0 mm sheath diameter, double-action functionality, and a 10-1/4" (26.0 cm) long handle. It has been tested for sterilization through Moist Heat or Steam Sterilization and is compliant with regulatory requirements. For detailed specifications and usage instructions, please refer to the Novo Surgical device manual.
Similar devices
Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
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- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
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
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
- Novo Surgical, Inc.
Sources (1)
- FDA UDI 2392b715-ba65-43cd-9014-b22b41e0cecf 37 fields · synced Jul 3, 2026