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FDA 510(k)

ORTHOPEDIC PACKS

K-Number: K951231 · 1995-12-01

ApplicantSterile Concepts, Inc.
Decision Date1995-12-01
Product CodeGAN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Concepts, Inc.. It received FDA 510(k) clearance on 1995-12-01 under 510(k) number K951231. The device is classified under product code GAN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPEDIC PACKS?

ORTHOPEDIC PACKS is a medical device that received FDA 510(k) clearance on 1995-12-01. The listed applicant is Sterile Concepts, Inc.. The 510(k) number is K951231.

When did ORTHOPEDIC PACKS receive FDA 510(k) clearance?

ORTHOPEDIC PACKS received FDA 510(k) clearance on 1995-12-01, under 510(k) number K951231.

Who is the listed applicant for ORTHOPEDIC PACKS?

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

What is the FDA product code for ORTHOPEDIC PACKS?

The FDA product code for ORTHOPEDIC PACKS is GAN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sterile Concepts, 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.

K951081OB/GYN PACKSK952539RADIOLOGY PACKSK951478GENERAL AND PLASTIC SURGERY PACKSK944139DENTAL HYGIENE TRAYK943047IV START KITSK943090SUTURE REMOVAL TRAYS

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Related Devices (Code: GAN)

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.

K003015SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBDSurgical Specialties CorpK964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDETHICON, Inc.K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)ETHICON, Inc.K920978ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYEDETHICON, Inc.K895579POLYSORB SYNTHETIC ABSORBABLE SUTUREUnited States Surgical, A Division of Tyco HealthcK900198DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.American Cyanamid Co.

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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