Cleared Traditional

K991827 - GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043

K991827 is an FDA 510(k) clearance for GINRAM SPECUVAG, manufactured by Ri Mos. S.R.L.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K991827 · Ri Mos. S.R.L. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
52d
Days
Class 2
Risk

K991827 is an FDA 510(k) clearance for the GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, .... Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Ri Mos. S.R.L. (Concord, US). The FDA issued a Cleared decision on July 19, 1999 after a review of 52 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 Ri Mos. S.R.L. devices

FDA 510(k) Submission Details - K991827

510(k) Number K991827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date July 19, 1999
Days to Decision 52 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 160d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIB Device Classification - Class 2, Special Controls

Product Code HIB Speculum, Vaginal, Nonmetal
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 - HIB Speculum, Vaginal, Nonmetal

All 21
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K991827.
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676 · Cypress Medical Products, Ltd. · Jul 2002
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
K992736 · Wallach Surgical Devices, Inc. · Sep 1999
PATTON SPECULUM
K991963 · Patton Medical Corp. · Sep 1999
VITALCARE DISPOSABLE VAGINAL SPECULUM
K983716 · Vitalcare Group, Inc. · Dec 1998
MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM
K984211 · Medscand AB · Dec 1998
KOLPLAST VAGINAL SPECULUM
K973853 · Kolplast Comercial E Industrial Ltda · Dec 1997