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FDA 510(k)

ASAP MUITISCOPE

K-Number: K121261 · 2013-01-08

ApplicantAsap Endoscopic Products GmbH
Decision Date2013-01-08
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASAP MUITISCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Asap Endoscopic Products GmbH. It received FDA 510(k) clearance on 2013-01-08 under 510(k) number K121261. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAP MUITISCOPE?

ASAP MUITISCOPE is a medical device that received FDA 510(k) clearance on 2013-01-08. The listed applicant is Asap Endoscopic Products GmbH. The 510(k) number is K121261.

When did ASAP MUITISCOPE receive FDA 510(k) clearance?

ASAP MUITISCOPE received FDA 510(k) clearance on 2013-01-08, under 510(k) number K121261.

Who is the listed applicant for ASAP MUITISCOPE?

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

What is the FDA product code for ASAP MUITISCOPE?

The FDA product code for ASAP MUITISCOPE is HRX.

Related Clinical Trials

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.

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Other records listing Asap Endoscopic Products 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.

K032822ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0K031974ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0K031972ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,K031141ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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