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FDA 510(k)

ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY

K-Number: K895182 · 1989-10-24

ApplicantAdvanced Surgical Intervention, Inc.
Decision Date1989-10-24
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY 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 1989-10-24 under 510(k) number K895182. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY?

ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Advanced Surgical Intervention, Inc.. The 510(k) number is K895182.

When did ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY receive FDA 510(k) clearance?

ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY received FDA 510(k) clearance on 1989-10-24, under 510(k) number K895182.

Who is the listed applicant for ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY?

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 ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY?

The FDA product code for ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY is FAJ.

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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: FAJ)

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.

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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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