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FDA 510(k)

HEWSON A.C.L. GUIDE SET

K-Number: K872608 · 1987-09-16

ApplicantConcept, Inc.
Decision Date1987-09-16
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEWSON A.C.L. GUIDE SET is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1987-09-16 under 510(k) number K872608. The device is classified under product code KGS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEWSON A.C.L. GUIDE SET?

HEWSON A.C.L. GUIDE SET is a medical device that received FDA 510(k) clearance on 1987-09-16. The listed applicant is Concept, Inc.. The 510(k) number is K872608.

When did HEWSON A.C.L. GUIDE SET receive FDA 510(k) clearance?

HEWSON A.C.L. GUIDE SET received FDA 510(k) clearance on 1987-09-16, under 510(k) number K872608.

Who is the listed applicant for HEWSON A.C.L. GUIDE SET?

The FDA 510(k) record lists Concept, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEWSON A.C.L. GUIDE SET?

The FDA product code for HEWSON A.C.L. GUIDE SET is KGS.

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Other records listing Concept, Inc. 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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Related Devices (Code: KGS)

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.

K030031SOFT TISSUE ANCHORING WASHERSAccu-Speed, IncorporatedK020480RBMSmith & Nephew, Inc.K964935SUTURE LOCKSmith & Nephew Endoscopy, Inc.K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, Inc.

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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