FDA 510(k)

28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES

K-Number: K881715 · 1988-08-30

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1988-08-30

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1988-08-30 under 510(k) number K881715. 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 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES?

28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K881715.

When did 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES receive FDA 510(k) clearance?

28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES received FDA 510(k) clearance on 1988-08-30, under 510(k) number K881715.

Who is the listed applicant for 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES?

The FDA product code for 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII System K223923HOPKINS Telescopes

View all 355 devices →

Related Devices (Code: HRX)

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC K253523Freedom DS™ Decompression SystemSpinal Simplicity K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC K253217MiiS 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

View on FDA Database →

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