Cleared Traditional

K881249 - BAGGISH

K881249 is the FDA 510(k) clearance for BAGGISH by Bryan Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K881249 · Bryan Corp. · Obstetrics & Gynecology device
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Jul 1988
Decision
127d
Days
Class 2
Risk

K881249 is an FDA 510(k) clearance for the BAGGISH, HYSTEROSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Bryan Corp. (Woburn, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - 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 Bryan Corp. devices

Submission Details

510(k) Number K881249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1988
Decision Date July 28, 1988
Days to Decision 127 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 160d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
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 - HIH Hysteroscope (and Accessories)

All 109
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K881249.
MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES
K882270 · KARL STORZ Endoscopy-America, Inc. · Oct 1989
OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE
K891451 · Olympus Corp. · Oct 1989
HYSTEROSCOPE AUTONOM 4992
K880314 · Richard Wolf Medical Instruments Corp. · Aug 1988
SCOPE LIGHT
K841825 · Zinnanti Surgical Instruments, Inc. · Jun 1984
CONTACT-MICRO COLPOHYSTEROSCOPE
K810569 · KARL STORZ Endoscopy-America, Inc. · Jul 1981