DISPOSABLE SUTURE PLACEMENT SYSTEM— 510(k) K932553
Substantially EquivalentLaurus Medical Corp.
FDA 510(k) clearance K932553 for DISPOSABLE SUTURE PLACEMENT SYSTEM, Substantially Equivalent on 1994-05-12. Applicant: Laurus Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Laurus Medical Corp.
- Product code
- 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
- Irvine, CA, US
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- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Laurus Medical Corp.
view allAdverse 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 →
Recalls naming K932553
K-number listed on FDA's recall record- Z-1618-2018 — Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
- Z-1620-2018 — Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932553.
Data sourced from openFDA. This site is unofficial and independent of the FDA.