Chrysalis Intelligence · Sponsors · Erbe USA, Inc.

Erbe USA, Inc.

Marietta, GA, US · 1 510(k) clearances · 3 recalls (3 Class I)

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Total clearances

1

2022-08-11 → 2022-08-11

Last 12 months

0

Product codes

1

Most recent

2022-08-11

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
OCX	—	—	—	1	2022-08-11

Safety

Recalls (3)

Class I (serious)

3

Risk of injury / death

Total recalls

3

Currently ongoing

3

Most recent

2026-02-12

Date	Severity	Status	Recall #	Product	Code	Reason
2026-02-12	Class I	Ongoing	Z-1568-2026	Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use	—	Probes may rupture/burst during activation
2026-02-12	Class I	Ongoing	Z-1567-2026	Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use	—	Probes may rupture/burst during activation
2026-02-12	Class I	Ongoing	Z-1566-2026	Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use	—	Probes may rupture/burst during activation

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2022-08-11	K221177	Erbe's Tubing/Cap Sets	OCX	—	—