Reflex SDD Surgical Stapler

FDA 510(k) K933508 · Richard-Allan Medical

Substantially Equivalent

510(k) numberK933508

Submission

Device name
Reflex SDD Surgical Stapler
Applicant
Richard-Allan Medical
Richland, MI, US
Received
July 20, 1993
Decision date
November 23, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GEF – Applier, Staple, Surgical,
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GEF

510(k)DeviceApplicantDecision
K915670Microaire Model 2600GEF · Traditional Microaire03/18/1992SE
K854568V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional American V. Mueller12/02/1985SE
K8238883M Frascia Stapling SystemGEF · Traditional 3M Company01/09/1983SE

More from 3M Company

510(k)DeviceDecision
K942207Reflex Ins Insufflation NeedleHIF · Traditional 05/27/1994SE
K935105Reflex Esp with Finger SwitchesGEI · Traditional 02/22/1994SE
K933901Reflex(R) Ehs (Endoscopic Hernia Stapler)GAG · Traditional 11/19/1993SE
K924881Reflex(R) EspGEI · Traditional 07/23/1993SE
K924929Reflex(R) EcaHBT · Traditional 07/21/1993SE
K905701Richard-Allan Sheet ClipKKX · Traditional 02/19/1991SE
K905682Richard-Allan Clamp CoversFSM · Traditional 02/19/1991SE

Questions and answers

When was Reflex SDD Surgical Stapler cleared by the FDA?

Reflex SDD Surgical Stapler (K933508) received a 510(k) decision of Substantially Equivalent on November 23, 1993, 126 days after the submission was received.

What is the product code of K933508?

The FDA product code is GEF – Applier, Staple, Surgical,, a Class I (low risk) device regulated under 21 CFR 878.4800.