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RenovaRP GIS-27

by GI Supply, Inc.

RenovaRP GIS-27 is a Class II device made by GI Supply, Inc., cleared under FDA 510(k) K970186 on 14 Feb 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00893029002076), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K970186

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00893029002076 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970186 Date14 Feb 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970186 decided 14 Feb 1997 Active
  • FDA GUDID UDI-DI 00893029002076 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K970186
  2. Listed FDA GUDID 00893029002076

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RenovaRP
Generic name
Surgical suction pump
Model / Ref / Catalog
GIS-27
Primary DI / UDI-DI
00893029002076
510(k) Number
FDA product code
BTA
GMDN term
Surgical suction pump
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical suction pump

Other devices from GI Supply, Inc.

See all devices from GI Supply, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)