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FDA 510(k)

GS-4100 REDUCER SLEEVE, 5MM TO 3MM

K-Number: K900961 · 1990-04-18

ApplicantSolos Endoscopy, Inc.
Decision Date1990-04-18
Product CodeFBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GS-4100 REDUCER SLEEVE, 5MM TO 3MM is the device name listed in this FDA 510(k) record. The listed applicant is Solos Endoscopy, Inc.. It received FDA 510(k) clearance on 1990-04-18 under 510(k) number K900961. The device is classified under product code FBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GS-4100 REDUCER SLEEVE, 5MM TO 3MM?

GS-4100 REDUCER SLEEVE, 5MM TO 3MM is a medical device that received FDA 510(k) clearance on 1990-04-18. The listed applicant is Solos Endoscopy, Inc.. The 510(k) number is K900961.

When did GS-4100 REDUCER SLEEVE, 5MM TO 3MM receive FDA 510(k) clearance?

GS-4100 REDUCER SLEEVE, 5MM TO 3MM received FDA 510(k) clearance on 1990-04-18, under 510(k) number K900961.

Who is the listed applicant for GS-4100 REDUCER SLEEVE, 5MM TO 3MM?

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

What is the FDA product code for GS-4100 REDUCER SLEEVE, 5MM TO 3MM?

The FDA product code for GS-4100 REDUCER SLEEVE, 5MM TO 3MM is FBM.

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.

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Other records listing Solos Endoscopy, 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.

K983538MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITYK910671MODEL GS-4700 COMMON DUCT STONE REMOVING KITK900956GS-7100 CHOLANGIOGRAM CLAMP, 5MMK900955GS-4000 REDUCER SLEEVE, 11MM TO 5MMK900964CANNULA AND TROCAR, 11MMK900954GS-5200 HOOK SUCTION/COAGULATOR, 5MM

View all 21 devices →

Related Devices (Code: FBM)

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.

K960400DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)Snowden-PencerK932021ENTREE CANNULA FASCIA ANCHORSCore Dynamics, Inc.K911813ENTREE CANNULACore Dynamics, Inc.K900965GS-4550 TROCAR ONLY, 11MMSolos Endoscopy, Inc.K900955GS-4000 REDUCER SLEEVE, 11MM TO 5MMSolos Endoscopy, Inc.K900963GS-4350 TROCAR ONLY, 5.5MMSolos Endoscopy, Inc.

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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