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FDA 510(k)

ELMED PNEUMOPERITONEUM NEEDLES

K-Number: K943624 · 1994-08-10

ApplicantHenke-Sass, Wolf GmbH
Decision Date1994-08-10
Product CodeFHO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELMED PNEUMOPERITONEUM NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Henke-Sass, Wolf GmbH. It received FDA 510(k) clearance on 1994-08-10 under 510(k) number K943624. 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 ELMED PNEUMOPERITONEUM NEEDLES?

ELMED PNEUMOPERITONEUM NEEDLES is a medical device that received FDA 510(k) clearance on 1994-08-10. The listed applicant is Henke-Sass, Wolf GmbH. The 510(k) number is K943624.

When did ELMED PNEUMOPERITONEUM NEEDLES receive FDA 510(k) clearance?

ELMED PNEUMOPERITONEUM NEEDLES received FDA 510(k) clearance on 1994-08-10, under 510(k) number K943624.

Who is the listed applicant for ELMED PNEUMOPERITONEUM NEEDLES?

The FDA 510(k) record lists Henke-Sass, Wolf GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELMED PNEUMOPERITONEUM NEEDLES?

The FDA product code for ELMED PNEUMOPERITONEUM NEEDLES is FHO.

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Other records listing Henke-Sass, Wolf GmbH 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.

K173070HSW Resection InstrumentsK171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathK101547HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)K952186HSW GMBH HYSTEROSCOPES & ACCESSORIESK941967HSW LAPAROSCOPE AND ACCESSORIES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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