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FDA 510(k)

ENDONEEDLE

K-Number: K844619 · 1985-01-09

ApplicantEndotherapeutics
Decision Date1985-01-09
Product CodeFHO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDONEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Endotherapeutics. It received FDA 510(k) clearance on 1985-01-09 under 510(k) number K844619. The device is classified under product code FHO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDONEEDLE?

ENDONEEDLE is a medical device that received FDA 510(k) clearance on 1985-01-09. The listed applicant is Endotherapeutics. The 510(k) number is K844619.

When did ENDONEEDLE receive FDA 510(k) clearance?

ENDONEEDLE received FDA 510(k) clearance on 1985-01-09, under 510(k) number K844619.

Who is the listed applicant for ENDONEEDLE?

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

What is the FDA product code for ENDONEEDLE?

The FDA product code for ENDONEEDLE is FHO.

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Other records listing Endotherapeutics 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.

K870855UROSCANK860192ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVEK860102MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLEK860103MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVEK852031ENDOPORT 5MMK841716ENDOPORT EROCAR

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Related Devices (Code: FHO)

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.

K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,LtdK121370VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLEVectecK010779MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTGibbons Surgical Corp.K970788PNEUMO-MATIC INSUFFLATION NEEDLEApple Medical Corp.K960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMSherwood Medical Co.K951894ACCESS EXPANSION SYSTEMMicro-Medical Devices, 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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