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)

Affirm 800

K-Number: K243077 · 2025-06-27

ApplicantDigital Surgery Systems, Inc. (D.B.A True Digital Surgery)
Decision Date2025-06-27
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Affirm 800 is the device name listed in this FDA 510(k) record. The listed applicant is Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243077. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Affirm 800?

Affirm 800 is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). The 510(k) number is K243077.

When did Affirm 800 receive FDA 510(k) clearance?

Affirm 800 received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243077.

Who is the listed applicant for Affirm 800?

The FDA 510(k) record lists Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Affirm 800?

The FDA product code for Affirm 800 is IZI.

Other records listing Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) 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.

K251286Affirm 400

Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbHK231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, 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.

↑