CLAMPS AND CLIPS— 510(k) K942896
Substantially EquivalentSurgin Surgical Instrumentation, Inc.
FDA 510(k) clearance K942896 for CLAMPS AND CLIPS, Substantially Equivalent on 1994-07-19. Applicant: Surgin Surgical Instrumentation, Inc.. Device class: 1.
Clearance details
- Applicant
- Surgin Surgical Instrumentation, Inc.
- Product code
- Code MDM
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Recent devices under product code MDM
view allMore clearances from Surgin Surgical Instrumentation, Inc.
view all- K082110 — DUAL SYRINGE HOLDER
- K033236 — PRIZM KERATOME BLADE, MODEL MK8512M2
- K033182 — PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
- K011195 — PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
- K994015 — ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
Adverse events under product code MDM
product code MDM- Injury
- 247
- Malfunction
- 1,516
- Total
- 1,763
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.