Product Code: HXD
FDA class 1
21 CFR 878.4800
Clamp
General, Plastic Surgery
A surgical clamp is a handheld instrument used to compress, secure, or occlude tissue, vessels, or organs during general and plastic surgical procedures. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating minimal risk and general controls only. Product code HXD falls under the General and Plastic Surgery medical specialty.
510(k)s
14
FEI Numbers
342
Registration Numbers
342
Unique Applicants
10
Years Active
12
Basic Information
- Product Code
- HXD
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K890381 | PARAMETRIUM CLAMP | Feb 03, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K890372 | INTESTINAL CLAMP | Feb 03, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K890371 | INTESTINAL CRUSHING CLAMP | Feb 03, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K890368 | KIDNEY CLAMP | Feb 03, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K874959 | VASCULAR CLAMP | Dec 30, 1987 | Substantially Equivalent | Solway, Inc. |
| K872386 | C CLAMP | Jul 02, 1987 | Substantially Equivalent | Med-Tool, Inc. |
| K863653 | SUCTION-OFF | Oct 07, 1986 | Substantially Equivalent | B&B Medical Technologies, Inc. |
| K853538 | CANNULA CLAMP | Sep 12, 1985 | Substantially Equivalent | Cp Medical |
| K851654 | OMNIMED CLAMP | May 31, 1985 | Substantially Equivalent | Omni Intl., Inc. |
| K801819 | SURGICAL INSTRUMENTS | Aug 20, 1980 | Substantially Equivalent | Robert I. Chien & Assoc., Inc. |
| K801028 | RICA OR SMIC SURGICAL INSTRUMENTS | May 20, 1980 | Substantially Equivalent | Robert I. Chien & Assoc., Inc. |
| K791289 | GIZMO TOWEL CLAMP | Jul 24, 1979 | Substantially Equivalent | Hemoy, Inc. |
| K782090 | CLAMP, DISPOSABLE | Dec 20, 1978 | Substantially Equivalent | Concord Laboratories, Inc. |
| K770118 | CARPENTER BONE CLAMP | Jan 26, 1977 | Substantially Equivalent | Stryker Corp. |
FEI Numbers
This FDA classification entry is associated with 342 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 342 registration numbers. Click on an entry to view related FDA registrations.