Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PROBE RETRACTOR, PART #S-2L8-6

K-Number: K770414 · 1977-04-15

ApplicantAcme United Corp.
Decision Date1977-04-15
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROBE RETRACTOR, PART #S-2L8-6 is the device name listed in this FDA 510(k) record. The listed applicant is Acme United Corp.. It received FDA 510(k) clearance on 1977-04-15 under 510(k) number K770414. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROBE RETRACTOR, PART #S-2L8-6?

PROBE RETRACTOR, PART #S-2L8-6 is a medical device that received FDA 510(k) clearance on 1977-04-15. The listed applicant is Acme United Corp.. The 510(k) number is K770414.

When did PROBE RETRACTOR, PART #S-2L8-6 receive FDA 510(k) clearance?

PROBE RETRACTOR, PART #S-2L8-6 received FDA 510(k) clearance on 1977-04-15, under 510(k) number K770414.

Who is the listed applicant for PROBE RETRACTOR, PART #S-2L8-6?

The FDA 510(k) record lists Acme United Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROBE RETRACTOR, PART #S-2L8-6?

The FDA product code for PROBE RETRACTOR, PART #S-2L8-6 is GAD.

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 Acme United Corp. 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.

K961323LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSINGK961452LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSINGK952565LYOFOAM EXTRAK895764MODIFIED LYOFOAM WOUND DRESSINGSK871740LYOSHEET SURGICAL SHEET FOR BURNSK864084LYOFOAM C ODOR-ABSORBING DRESSING

View all 27 devices →

Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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.

↑