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FDA 510(k)

PROBE

K-Number: K841624 · 1984-08-27

ApplicantPlastafil, Inc.
Decision Date1984-08-27
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Plastafil, Inc.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K841624. 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 PROBE?

PROBE is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Plastafil, Inc.. The 510(k) number is K841624.

When did PROBE receive FDA 510(k) clearance?

PROBE received FDA 510(k) clearance on 1984-08-27, under 510(k) number K841624.

Who is the listed applicant for PROBE?

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

What is the FDA product code for PROBE?

The FDA product code for PROBE is HRX.

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Other records listing Plastafil, Inc. 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.

K841621BACK RADIUS CUTTERK841620FRONT RADIUS CUTTERK841625HOOKK841617STROVER HOOKK841626PUNCHK841629DRILL BIT

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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

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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