Chrysalis Intelligence · Product Codes · NAY

NAY · System, Surgical, Computer Controlled Instrument

Gastroenterology, Urology · 63 clearances · 4 unique sponsors

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Device class
Class II
Regulation 876.1500
Total clearances
63
2020-02-06 → 2026-07-31
Last 12 months
13
Unique sponsors
4
Definition

What is System, Surgical, Computer Controlled Instrument

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification details
Medical specialty
Gastroenterology, Urology
Review panel
SU
Regulation number
876.1500
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Intuitive Surgical, Inc. 54 12 2026-07-31
Asensus Surgical, Inc. 6 1 2026-05-12
Transenterix, Inc. 2 0 2021-03-02
Aktormed GmbH 1 0 2020-12-22
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
43289 CPT — Low Computer-controlled endoscopic surgical instruments billed with specific procedure codes
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-31 K261824 Intuitive Surgical, Inc. da Vinci Surgical System, Model IS5000
2026-05-22 K260695 Intuitive Surgical da Vinci Firefly Imaging System
2026-05-12 K254192 Asensus Surgical Senhance Ultrasonic System
2026-03-11 K253986 Intuitive Surgical, Inc. da Vinci Force Feedback Instruments
2026-01-16 K253556 Intuitive Surgical, Inc. da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
2026-01-16 K251739 Intuitive Surgical, Inc. da Vinci Surgical System (IS5000)
2025-12-15 K252675 Intuitive Surgical, Inc. da Vinci SP Surgical System (SP1098)
2025-12-02 K252069 Intuitive Surgical, Inc. da Vinci SP Surgical System (SP1098)
2025-10-03 K251426 Intuitive Surgical, Inc. da Vinci SP Surgical System (SP1098)
2025-09-10 K251817 Intuitive Surgical, Inc. da Vinci SP Surgical System (SP1098)
2025-09-08 K251227 Intuitive Surgical, Inc. da Vinci Surgical System (IS5000)
2025-08-29 K251324 Intuitive Surgical, Inc. da Vinci SP Surgical System (SP1098)
2025-08-28 K252350 Intuitive Surgical, Inc. da Vinci SP Firefly Imaging System
2025-07-29 K250442 Intuitive Surgical, Inc. da Vinci Surgical System, IS5000
2025-07-23 K251213 Intuitive Surgical, Inc. Da Vinci Surgical System (IS5000)
2025-07-16 K251202 Intuitive Surgical, Inc. da Vinci Surgical System (IS5000)
2025-06-13 K250674 Intuitive Surgical, Inc. Vessel Sealer Curved (480522)
2025-06-11 K240852 Intuitive Surgical, Inc. da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
2025-05-13 K250786 Intuitive Surgical, Inc. SP Endoscope, 0° (430600)
2025-04-24 K243714 Intuitive Surgical, Inc. da Vinci SP Surgical System (SP1098)
2025-04-01 K242427 Intuitive Surgical, Inc. da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
2025-02-28 K243582 Intuitive Surgical, Inc. da Vinci SP Advanced Access Port Kit (432701)
2024-12-16 K243641 Intuitive Surgical, Inc. da Vinci Surgical System (IS5000)
2024-11-26 K242318 Intuitive Surgical, Inc. da Vinci SP Surgical System (SP1098)
2024-11-18 K241814 Intuitive Surgical, Inc. da Vinci SP Instruments (SP1098)
Data source: openFDA · Generated 2026-08-18 09:10 · Last ingest 2026-08-18T13:09:43.467718 · Pipeline: Chrysalis Intelligence