NLQ · Single-Use Reprocessed Ultrasonic Surgical Instruments

Device class

Unclassified

Regulation —

Total clearances

2020-08-19 → 2025-08-14

Last 12 months

Unique sponsors

Definition

What is Single-Use Reprocessed Ultrasonic Surgical Instruments

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code LFL). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Classification details

Medical specialty

Unknown

Review panel

Regulation number

—

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Stryker Sustainability Solutions	4	0	2025-08-14
Surgical Instrument Service and Savings Inc.(Dba Medline Ren	1	0	2020-08-19

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.

Code	Type	Description	Confidence	Rationale
76998	CPT	—	Medium	Ultrasonic surgical device use; exact billing depends on surgical context and parent device LFL
76999	CPT	—	Medium	Alternative ultrasonic surgical procedure code depending on specific application

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-08-14	K250898	Stryker Sustainability Solutions	Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)
2024-07-03	K241606	Stryker Sustainability Solutions	Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
2024-02-20	K233471	Stryker Sustainability Solutions	Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
2021-03-16	K202554	Stryker Sustainability Solutions	Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
2020-08-19	K193563	Surgical Instrument Service and Savings Inc.(Dba Medline Ren	Medline ReNewal Reprocessed Harmonic ACE+7 Shears