SURGIN IRRIGATION PUMP— 510(k) K942641
Substantially EquivalentSurgin Surgical Instrumentation, Inc.
FDA 510(k) clearance K942641 for SURGIN IRRIGATION PUMP, Substantially Equivalent on 1994-07-07. Applicant: Surgin Surgical Instrumentation, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgin Surgical Instrumentation, Inc.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Recent devices under product code GCJ
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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 GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.