Snare, Surgical
The Snare, Surgical (product code GAE) is a looped wire or cord instrument used during surgery to encircle and excise polyps, lesions, or tissue masses in general and plastic surgery settings. It is classified as FDA Class 1, posing the lowest level of risk, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GAE
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950776 | BIPOLAR SNARE | Apr 18, 1995 | Substantially Equivalent | Cook Urological, Inc. |
| K926036 | ACUFEX SUTURE RETRIEVER | May 05, 1993 | Substantially Equivalent | Acufex Microsurgical, Inc. |
| K903174 | ADVANCE SUTURE ABSORBABLE GUT SUTURE | Jul 10, 1991 | Substantially Equivalent | Advance Suture, Inc. |
| K881224 | ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE | Jun 01, 1988 | Substantially Equivalent | Acufex Microsurgical, Inc. |
FEI Numbers
This FDA classification entry is associated with 66 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 66 registration numbers. Click on an entry to view related FDA registrations.