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FDA 510(k)

REFLEX SDD SURGICAL STAPLER

K-Number: K933508 · 1993-11-23

ApplicantRichard-Allan Medical
Decision Date1993-11-23
Product CodeGEF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REFLEX SDD SURGICAL STAPLER is the device name listed in this FDA 510(k) record. The listed applicant is Richard-Allan Medical. It received FDA 510(k) clearance on 1993-11-23 under 510(k) number K933508. The device is classified under product code GEF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLEX SDD SURGICAL STAPLER?

REFLEX SDD SURGICAL STAPLER is a medical device that received FDA 510(k) clearance on 1993-11-23. The listed applicant is Richard-Allan Medical. The 510(k) number is K933508.

When did REFLEX SDD SURGICAL STAPLER receive FDA 510(k) clearance?

REFLEX SDD SURGICAL STAPLER received FDA 510(k) clearance on 1993-11-23, under 510(k) number K933508.

Who is the listed applicant for REFLEX SDD SURGICAL STAPLER?

The FDA 510(k) record lists Richard-Allan Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLEX SDD SURGICAL STAPLER?

The FDA product code for REFLEX SDD SURGICAL STAPLER is GEF.

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Other records listing Richard-Allan Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942207REFLEX INS INSUFFLATION NEEDLEK935105REFLEX ESP WITH FINGER SWITCHESK933901REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)K924881REFLEX(R) ESPK924929REFLEX(R) ECAK905701RICHARD-ALLAN SHEET CLIP

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Related Devices (Code: GEF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K915670MICROAIRE MODEL 2600MicroaireK854568V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAPAmerican V. MuellerK8238883M FRASCIA STAPLING SYSTEM3M Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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