Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ORS-300

K-Number: K921570 · 1992-06-09

ApplicantMnlase, Inc.
Decision Date1992-06-09
Product CodeJRM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORS-300 is the device name listed in this FDA 510(k) record. The listed applicant is Mnlase, Inc.. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K921570. The device is classified under product code JRM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORS-300?

ORS-300 is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is Mnlase, Inc.. The 510(k) number is K921570.

When did ORS-300 receive FDA 510(k) clearance?

ORS-300 received FDA 510(k) clearance on 1992-06-09, under 510(k) number K921570.

Who is the listed applicant for ORS-300?

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

What is the FDA product code for ORS-300?

The FDA product code for ORS-300 is JRM.

Other records listing Mnlase, 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.

K944630MODEL 230-SAS LASER DELIVERY PROBEK944625MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASERK944470CURVED ENDOPHOTOCOAGULATOR LASER PROBEK944628MODEL 220-SS LASER DELIVERY PROBEK944471STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBEK944629MODEL 230-SAC LASER DELIVERY PROBE

View all 22 devices →

Related Devices (Code: JRM)

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.

K921569ORS-200Mnlase, Inc.K921568ORS-100Mnlase, Inc.K915427ORS-1000Mnlase, Inc.K913777SELF-CONTAINED SURGICAL SLUSH FREEZERTaylor Corp.K894006SANISERV SURGICAL SLUSH SYSTEMSaniserv, Inc.K782077LANCER ICE CUBESherwood Medical Industries

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.

↑