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FDA 510(k)

CORE DISPOSABLE INSUFFLATION TUBING

K-Number: K901413 · 1990-09-24

ApplicantCore Dynamics, Inc.
Decision Date1990-09-24
Product CodeHES
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CORE DISPOSABLE INSUFFLATION TUBING 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 1990-09-24 under 510(k) number K901413. The device is classified under product code HES. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE DISPOSABLE INSUFFLATION TUBING?

CORE DISPOSABLE INSUFFLATION TUBING is a medical device that received FDA 510(k) clearance on 1990-09-24. The listed applicant is Core Dynamics, Inc.. The 510(k) number is K901413.

When did CORE DISPOSABLE INSUFFLATION TUBING receive FDA 510(k) clearance?

CORE DISPOSABLE INSUFFLATION TUBING received FDA 510(k) clearance on 1990-09-24, under 510(k) number K901413.

Who is the listed applicant for CORE DISPOSABLE INSUFFLATION TUBING?

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 CORE DISPOSABLE INSUFFLATION TUBING?

The FDA product code for CORE DISPOSABLE INSUFFLATION TUBING is HES.

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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: HES)

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.

K000340HYSTALOG HSG CATHETERRocket Medical PlcK903209MAXI-FLOW INSUFFLATOR TUBING SET W/FILTERAdler Instrument Co.K903208MAXI-FLOW INSUFFLATOR TUBING SETAdler Instrument Co.K904473KRONNER MANIPUJECTORUnimar, Inc.K891290SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETERCook Ob/GynK890869BARD HYSTEROSALPINGOGRAPHY CATHETERSC.R. Bard, 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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