Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Laparoscopic tissue manipulation forceps/working-channel FDA UDI
- Device Name
- Silicone Flush Port Caps - Must Purchase as a pack of 100 from the Vendor FDA UDI
- Model / Reference
- SD55A FDA UDI
- Description
- Silicone Flush Port Caps - Must Purchase as a pack of 100 from the Vendor FDA UDI
Identifiers
- Catalog Number
- SD55A FDA UDI
- Primary DI / UDI-DI
- B382SD55A0 FDA UDI
- 510(k) Number
- K914910 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Laparoscopic tissue manipulation forceps/working-channel 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Laparoscopic tissue manipulation forceps/working-channel
Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic tissue manipulation forceps/working-channel.
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Symmetry Surgical — SYMMETRY SURGICAL INC. · Class I
- Snowden-Pencer — STERIS CORPORATION · Class II
- Kumar Clamp® for Single Port, Bariatrics and Robotics — NASHVILLE SURGICAL INSTRUMENTS · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
Cleared under the same submission
K914910 also covers:
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, 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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 296bcd5c-aee2-4485-b391-9190def4f890 36 fields · synced Jun 8, 2026