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)

FS-38H, FIBER SIGMOIDOSCOPE

K-Number: K951573 · 1995-06-27

ApplicantPentax Precision Instrument Corp.
Decision Date1995-06-27
Product CodeFAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FS-38H, FIBER SIGMOIDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Precision Instrument Corp.. It received FDA 510(k) clearance on 1995-06-27 under 510(k) number K951573. The device is classified under product code FAM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FS-38H, FIBER SIGMOIDOSCOPE?

FS-38H, FIBER SIGMOIDOSCOPE is a medical device that received FDA 510(k) clearance on 1995-06-27. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K951573.

When did FS-38H, FIBER SIGMOIDOSCOPE receive FDA 510(k) clearance?

FS-38H, FIBER SIGMOIDOSCOPE received FDA 510(k) clearance on 1995-06-27, under 510(k) number K951573.

Who is the listed applicant for FS-38H, FIBER SIGMOIDOSCOPE?

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

What is the FDA product code for FS-38H, FIBER SIGMOIDOSCOPE?

The FDA product code for FS-38H, FIBER SIGMOIDOSCOPE is FAM.

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 Pentax Precision Instrument 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.

K041397EG-3830UTK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK041395EG-3630URK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

View all 67 devices →

Related Devices (Code: FAM)

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.

K964131ENDOSCOPEAkos Biomedical, Inc.K970382VS-100 VIDEO SIGMOIDOSCOPEWelch Allyn, Inc.K964326VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEMVision-Sciences, Inc.K964100VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100Vision-Sciences, Inc.K963344DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPEVision-Sciences, Inc.K961567ES-3840, VIDEO SIGMOIDOSCOPEPentax Precision Instrument Corp.

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.

↑