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FDA 510(k)

URETHRAL DILATOR ENDOSCOPE

K-Number: K874530 · 1988-01-27

ApplicantAdvanced Surgical Intervention, Inc.
Decision Date1988-01-27
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETHRAL DILATOR ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Intervention, Inc.. It received FDA 510(k) clearance on 1988-01-27 under 510(k) number K874530. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URETHRAL DILATOR ENDOSCOPE?

URETHRAL DILATOR ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1988-01-27. The listed applicant is Advanced Surgical Intervention, Inc.. The 510(k) number is K874530.

When did URETHRAL DILATOR ENDOSCOPE receive FDA 510(k) clearance?

URETHRAL DILATOR ENDOSCOPE received FDA 510(k) clearance on 1988-01-27, under 510(k) number K874530.

Who is the listed applicant for URETHRAL DILATOR ENDOSCOPE?

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

What is the FDA product code for URETHRAL DILATOR ENDOSCOPE?

The FDA product code for URETHRAL DILATOR ENDOSCOPE is KOB.

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Other records listing Advanced Surgical Intervention, 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.

K954215MINIGUARDK926110ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENTK930361ASI CYSTOLASE LASER CYSTOSCOPEK921990ASI UROPLASTY LASER CYSTOSCOPEK902585UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETERK901336ASI HEMOSTASIS CATHETER

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Related Devices (Code: KOB)

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.

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K181097Cook Cystostomy Catheter SetCook IncorporatedK182709One-Step Suprapubic IntroducerCook IncorporatedK182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook IncorporatedK120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, IncorporatedK014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical 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.

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