Cleared Traditional

K882270 - MODELS 27040 & 27050 CONTI. FLOW RESECT...

K882270 is the FDA 510(k) clearance for MODELS 27040 & 27050 CONTI. FLOW RESECT... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 507-day FDA review.

K882270 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
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Oct 1989
Decision
507d
Days
Class 2
Risk

K882270 is an FDA 510(k) clearance for the MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on October 20, 1989 after a review of 507 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K882270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date October 20, 1989
Days to Decision 507 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
347d slower than avg
Panel avg: 160d · This submission: 507d
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 108
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K882270.
CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY
K895857 · Richard Wolf Medical Instruments Corp. · Jun 1990
OLYMPUS HYSTERORESECTOSCOPE
K897003 · Olympus Corp. · Mar 1990
HYSTEROSCOPE
K896917 · Cabot Medical Corp. · Mar 1990
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