ENDO-JUDGE
FDA 510(k) clearance K932591 · decided 1993-12-22
Clearance details
- K-number
- K932591
- Device name
- ENDO-JUDGE
- Applicant
- Synergistic Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-28
- Decision date
- 1993-12-22
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- GAB
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| DIGICAP (K012199) | Humana USA, Inc. | 2001-12-19 |
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| CONTRAST BACKGROUND MATERIAL (K895681) | Applied Medical Technologies | 1989-10-24 |
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| ANCHOR BRAND SURGICAL NEEDLES (K831648) | Anchor Products Co. | 1983-08-16 |
| RADIATION STERILIZATION FOR NEEDLE CNTR (K812444) | Devon Industries, Inc. | 1981-12-14 |
| SCANLAN STERNUM NEEDLE-SUTURE (K801976) | Scanlan Intl., Inc. | 1980-09-26 |
Recalls involving this device
No recalls on record reference this clearance.