Cleared Traditional

K891347 - REID ENDOCERVICAL SPREADER

K891347 is an FDA 510(k) clearance for REID ENDOCERVICAL SPREADER, manufactured by Simpson/Basye, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDC cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K891347 · Simpson/Basye, Inc. · Obstetrics & Gynecology device
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Mar 1989
Decision
19d
Days
Class 2
Risk

K891347 is an FDA 510(k) clearance for the REID ENDOCERVICAL SPREADER. Classified as Tenaculum, Uterine (product code HDC), Class II - Special Controls.

Submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on March 29, 1989 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Simpson/Basye, Inc. devices

FDA 510(k) Submission Details - K891347

510(k) Number K891347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1989
Decision Date March 29, 1989
Days to Decision 19 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
141d faster than avg
Panel avg: 160d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDC Device Classification - Class 2, Special Controls

Product Code HDC Tenaculum, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HDC Tenaculum, Uterine

All 13
Devices cleared under the same product code (HDC) and FDA review panel - the closest regulatory comparables to K891347.
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
K980247 · Gynex Corp. · Mar 1998
ATRAUMATIC TENACULA
K930037 · Thomasville Medical Assoc. · Feb 1994
OTT CERVICAL TENACULUM
K910287 · Marlo Surgical Technology · Feb 1991
ATRAUMATIC TENACULA
K891033 · Zinnanti Surgical Instruments, Inc. · Mar 1989
UTERINE TENTACULUM
K890379 · Kinetic Medical Products · Feb 1989