Cleared Traditional

K911326 - OBSTETRICAL VACUUM CUP

K911326 is an FDA 510(k) clearance for OBSTETRICAL VACUUM CUP, manufactured by Gesco Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDB cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K911326 · Gesco Intl., Inc. · Obstetrics & Gynecology device
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Aug 1991
Decision
141d
Days
Class 2
Risk

K911326 is an FDA 510(k) clearance for the OBSTETRICAL VACUUM CUP. Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on August 14, 1991 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4340 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gesco Intl., Inc. devices

FDA 510(k) Submission Details - K911326

510(k) Number K911326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date August 14, 1991
Days to Decision 141 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 160d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDB Device Classification - Class 2, Special Controls

Product Code HDB Extractor, Vacuum, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HDB Extractor, Vacuum, Fetal

All 7
Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K911326.
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M)
K250298 · Clinical Innovations, LLC · Oct 2025
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
K041579 · Medela AG · Apr 2005
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K980976 · Hollister, Inc. · Aug 1998
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
K895700 · Hollister, Inc. · Apr 1990
AB VACUUM EXTRACTOR SILC-CUP
K841492 · Medela, Inc. · May 1984
MEDELA SUCTION PUMP
K830012 · Medela, Inc. · Jan 1983