MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000— 510(k) K121336

Name: FDA 510(k) clearance K121336
Creator: U.S. Food and Drug Administration
Published: 2012-07-03

Substantially Equivalent

Surgiquest, Inc.

FDA 510(k) clearance K121336 for MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000, Substantially Equivalent on 2012-07-03. Applicant: Surgiquest, Inc.. Device class: 2.

Clearance details

Applicant: Surgiquest, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 2012-05-03
Decision date: 2012-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Milford, CT, US

Download summary PDF View on FDA.gov ↗

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K252318 — Insufflator (OPTO-IFL1000)2026-04-16
K250388 — ENDOFLATOR +2025-09-22
K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11

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K103692 — SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 20002011-05-25
K100180 — SURGIQUEST ANCHORPORT SIL KIT2010-05-05
K092504 — SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM2009-11-05

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.