HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length— 510(k) K191555
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K191555 for HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length, Substantially Equivalent on 2020-02-28. Applicant: Ethicon Endo-Surgery, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- Product code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guaynabo, PR, US
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More clearances from Ethicon Endo-Surgery, LLC
view all- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K260196 — ETHICON Circular Stapler (CDH21mm) +7 more
- K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
- K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more
- K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K191555
K-number listed on FDA's recall record- Z-2355-2021 — HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
- Z-2356-2021 — HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191555.
Data sourced from openFDA. This site is unofficial and independent of the FDA.