Standard Clamp Disposable SCD22-1
FDA UDIFDA 510(k)Class II (US FDA UDI)
Identity
- Trade Name
- Standard Clamp, Disposable FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, single-use FDA UDI
- Model / Reference
- SCD22-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851677007027 FDA UDI
- 510(k) Number
- K190788 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid 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
Yes
Single Use
Yes
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
Yes
Manufacturing Date
Yes
Category: Rigid endoscopic tissue manipulation forceps, single-use
The Standard Clamp Disposable SCD22-1 is a rigid endoscopic tissue manipulation forceps, classified as a single-use device. It features scissors-like handles, a rigid long slender shaft, and distal grasping jaws designed for introduction through an endoscope or laparoscopic port. This instrument is intended for grasping and manipulating tissues during endoscopic surgery, excluding electrosurgical functions or biopsy procedures.
This device is supplied sterile, single-use, and intended for use in laparoscopic procedures such as bariatric surgeries (e.g., sleeve gastrectomy). It is not MRI-safe, as per labeling, and includes an expiration date. Each package contains one unit, with lot/batch and manufacturing date markings. The device holds an FDA 510(k) clearance (K161720) and is classified under product code GCJ for laparoscopic, general, and plastic surgery applications.
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Frequently asked questions
What types of surgeries is this clamp specifically designed for, and how is it introduced into the body?
The Standard Clamp Disposable (SCD22-1) is designed for laparoscopic procedures, particularly bariatric surgeries like sleeve gastrectomy. It is introduced through an endoscope or laparoscopic port due to its rigid, long slender shaft and scissors-like handles, allowing precise tissue grasping and manipulation during minimally invasive surgery.
Is this clamp reusable, and if not, what does the packaging include?
No, this clamp is explicitly labeled as a single-use device. Each package contains one sterile unit, and the packaging includes markings for lot/batch and manufacturing dates, along with an expiration date to ensure proper usage within its valid period.
Can this clamp be used with MRI machines, and what safety precautions should be taken?
The Standard Clamp Disposable is not MRI-safe, as explicitly stated in its labeling. If MRI imaging is required during or after use, the clamp must be removed from the patient’s body and disposed of safely, as it could interfere with MRI procedures or pose a risk.
How do I identify the correct model and ensure I’m using a valid unit before surgery?
The model number for this clamp is SCD22-1. To verify validity, check the package for the lot/batch number, manufacturing date, and expiration date. These markings ensure the unit is sterile, within its shelf life, and intended for single-use only.
What regulatory pathway does this device follow, and which medical specialties are associated with its use?
This clamp holds an FDA 510(k) clearance (K161720) under product code GCJ, classified for laparoscopic, general, and plastic surgery. It is associated with the advisory committees for Gastroenterology and Urology, reflecting its primary use in procedures like bariatric surgeries within those specialties.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Standard Bariatrics Standard Clamp, Disposable, Disposable Standard Clamp (K190788) — FDA 510(k) | Innolitics, Disposable Standard Clamp (K181608) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190788 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181608 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K161720 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K153358 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170379 | Class II | Active |
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Manufacturer
- Manufacturer
- Standard Bariatrics
Sources (2)
- FDA UDI 86c81c0f-60df-481b-9372-4f44b8a784de 57 fields · synced Sep 18, 2026
- FDA 510(k) K190788 1 fields · synced Jun 5, 2026