FDA 510(k)

DASH

K-Number: K071775 · 2007-08-07

Decision Date2007-08-07

Product CodeGAD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DASH is the device name listed in this FDA 510(k) record. The listed applicant is Ezsurgical. It received FDA 510(k) clearance on 2007-08-07 under 510(k) number K071775. 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 DASH?

DASH is a medical device that received FDA 510(k) clearance on 2007-08-07. The listed applicant is Ezsurgical. The 510(k) number is K071775.

When did DASH receive FDA 510(k) clearance?

DASH received FDA 510(k) clearance on 2007-08-07, under 510(k) number K071775.

Who is the listed applicant for DASH?

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

What is the FDA product code for DASH?

The FDA product code for DASH is GAD.

Other records listing Ezsurgical 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.

K082291A-LAP SET (A-LAP, EZAXESS, TROCAR)

Related Devices (Code: GAD)

K152538JRP Wound SpreaderJ.R. Parker, LLC K151104OTELO LLSpineart K132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek K001339MRI 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.