# K991563: Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C

- Pathway: 510(k) (Traditional)
- Applicant: Henke Sass Wolf of America, Inc.
- Decided: Oct 13, 1999 after 161 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954050 (1995). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954050: Resectoscopes, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 1.
- (no number) Henke Sass Wolf GmbH Hysteroscopes and Accessories: named in the summary without a submission number
- (no number) Smith & Nephew Dyonics Hysteroscopes and Accessories: named in the summary without a submission number
- (no number) Cooper Surgical RG-27 Series Resectoscope and Accessories: named in the summary without a submission number
- (no number) Cooper Surgical HT4 Series Hysteroscopes and Accessories: named in the summary without a submission number
- (no number) Karl Storz Endoscopic Hysteroscopes and Accessories: named in the summary without a submission number
- (no number) Gyrus Axipoler: named in the summary without a submission number
- (no number) Omnitech Systems Inc. Resectoscope Electrodes: named in the summary without a submission number

## Most influential descendants
- K091465: Myosure Rod Lens Hysteroscope (2009), 4 descendants of its own
- K122563: Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel (2012), 2 descendants of its own
- K182006: Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths (2018), 1 descendant of its own
- K191281: Omni Hysteroscope, Omni Lok cervical seal (2019), 0 descendants of its own
- K123330: Iogyn Endoscope (2013), 0 descendants of its own

## Indications for use
The HENKE SASS WOLF Hysteroscopic Resectoscopes are intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. The HENKE SASS WOLF Resectoscopes and Accessories will include the Sheaths - to establish portals for visualization and surgical access and the electrode devices indicated for resection/coagulation for soft tissue and are intended for the use with the compatible resectoscopes. The Resectoscopes and Accessories are indicated for use in diagnostic examination and therapeutic surgical procedures of but not limited to: Urological and Gynecological Fields. The surgical applications may include: Tissue Cutting, removal, and dissection as required or encountered in but not limited to: Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa

Source page: https://510kreport.com/device/K991563
Methodology: https://510kreport.com/methodology