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.

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
20d faster than avg
Panel avg: 161d · 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 22
Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K911326.
CMI VELVET TOUCH VACUUM EXTRACTOR
K942725 · Columbia Medical & Surgical, Inc. · May 1995
MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE
K943938 · Neward Enterprises, Inc. · May 1995
MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
K934011 · Neward Enterprises, Inc. · May 1994
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
K895700 · Hollister, Inc. · Apr 1990
CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)
K895446 · Challenge Mfg., Inc. · Nov 1989
AB VACUUM EXTRACTOR SILC-CUP
K841492 · Medela, Inc. · May 1984
K911326 · OBSTETRICAL VACUUM CUP
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