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FDA 510(k)

ENTREE CANNULA

K-Number: K911813 · 1991-07-19

ApplicantCore Dynamics, Inc.
Decision Date1991-07-19
Product CodeFBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTREE CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Core Dynamics, Inc.. It received FDA 510(k) clearance on 1991-07-19 under 510(k) number K911813. 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 ENTREE CANNULA?

ENTREE CANNULA is a medical device that received FDA 510(k) clearance on 1991-07-19. The listed applicant is Core Dynamics, Inc.. The 510(k) number is K911813.

When did ENTREE CANNULA receive FDA 510(k) clearance?

ENTREE CANNULA received FDA 510(k) clearance on 1991-07-19, under 510(k) number K911813.

Who is the listed applicant for ENTREE CANNULA?

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

What is the FDA product code for ENTREE CANNULA?

The FDA product code for ENTREE CANNULA is FBM.

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Other records listing Core Dynamics, 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.

K992250CORE AUDIBLE TROCAR IIK992190CORE POUCHK955490LAPAROSCOPIC KNITTERK953903LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MMK953409LAPAROSCOPIC TROCARK950457CANNUAL AND TROCAR, SUPERPUBIC

View all 23 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.K900961GS-4100 REDUCER SLEEVE, 5MM TO 3MMSolos Endoscopy, Inc.K900962GS-4300 CANNULA AND TROCAR, 5.5MMSolos 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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