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FDA 510(k)

PNEUMO-MATIC INSUFFLATION NEEDLE

K-Number: K970788 · 1997-03-27

ApplicantApple Medical Corp.
Decision Date1997-03-27
Product CodeFHO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PNEUMO-MATIC INSUFFLATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Apple Medical Corp.. It received FDA 510(k) clearance on 1997-03-27 under 510(k) number K970788. 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 PNEUMO-MATIC INSUFFLATION NEEDLE?

PNEUMO-MATIC INSUFFLATION NEEDLE is a medical device that received FDA 510(k) clearance on 1997-03-27. The listed applicant is Apple Medical Corp.. The 510(k) number is K970788.

When did PNEUMO-MATIC INSUFFLATION NEEDLE receive FDA 510(k) clearance?

PNEUMO-MATIC INSUFFLATION NEEDLE received FDA 510(k) clearance on 1997-03-27, under 510(k) number K970788.

Who is the listed applicant for PNEUMO-MATIC INSUFFLATION NEEDLE?

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

What is the FDA product code for PNEUMO-MATIC INSUFFLATION NEEDLE?

The FDA product code for PNEUMO-MATIC INSUFFLATION NEEDLE is FHO.

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Other records listing Apple Medical Corp. 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.

K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158K050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORK041131APPLE MEDICAL OB MOBIUS ELASTIC RETRACTORK014005APPLE MEDICAL MOBIUS ELASTIC RETRACTORK000026APPLE MEDICAL ONE-TOUCH UTERINE SAMPLERK961460LWEET CONE BIOPSY INSTRUMENT

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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.K960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMSherwood Medical Co.K951894ACCESS EXPANSION SYSTEMMicro-Medical Devices, Inc.K943624ELMED PNEUMOPERITONEUM NEEDLESHenke-Sass, Wolf GmbH

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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