Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- Seal Cap Housing FDA UDI
- Model / Reference
- SD77205-20014 FDA UDI
- Description
- Seal Cap Housing FDA UDI
Identifiers
- Catalog Number
- SD77205-20014 FDA UDI
- Primary DI / UDI-DI
- B382SD77205200140 FDA UDI
- 510(k) Number
- K974382 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Flexible endoscopic tissue manipulation forceps, single-use 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
No
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
Category: Flexible endoscopic tissue manipulation forceps, single-use
Surgical Direct Surgical Direct is a flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device. Implantable: false
Similar devices
Also classified as Flexible endoscopic tissue manipulation forceps, single-use.
- Cook — COOK INCORPORATED · Class II
- LiNA CystoVu™ HD Grasper — Lina Medical ApS · Class II
- Cook — COOK INCORPORATED · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, 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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI f26c7f2e-1f80-4100-a165-737f725d0148 36 fields · synced Jul 26, 2026