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FDA 510(k)

APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR

K-Number: K050256 · 2005-04-26

ApplicantApple Medical Corp.
Decision Date2005-04-26
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR 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 2005-04-26 under 510(k) number K050256. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR?

APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR is a medical device that received FDA 510(k) clearance on 2005-04-26. The listed applicant is Apple Medical Corp.. The 510(k) number is K050256.

When did APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR receive FDA 510(k) clearance?

APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR received FDA 510(k) clearance on 2005-04-26, under 510(k) number K050256.

Who is the listed applicant for APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR?

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 APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR?

The FDA product code for APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR is GAD.

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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 158K041131APPLE MEDICAL OB MOBIUS ELASTIC RETRACTORK014005APPLE MEDICAL MOBIUS ELASTIC RETRACTORK000026APPLE MEDICAL ONE-TOUCH UTERINE SAMPLERK970788PNEUMO-MATIC INSUFFLATION NEEDLEK961460LWEET CONE BIOPSY INSTRUMENT

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Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor DanekK001339MRI FASTSYSTEM RETRACTOR SYSTEMOmni-Tract Surgical, Div. Minn. Scientific, 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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